Watson gets FDA final approval for generic Actos; negative news on Prochieve appeal

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) said on Friday that it has launched a generic version of Japanese drug major Takeda’s (TYO: 4502) type 2 diabetes drug Actos (pioglitazone 15mg, 30mg and 45mg tablets) after receiving final approval from the US Food and Drug Administration, and began shipping the product immediately.

On August 15, 2012, Watson announced that it had filed suit against the FDA challenging the agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos. Mylan Pharmaceuticals subsequently intervened as a defendant in the action. On October 22, 2012, the US District Court for the District of Columbia granted summary judgment in favor of Watson and ordered the FDA to approve the firm’s Abbreviated New Drug Application. Mylan appealed the judgment to the US Court of Appeals for the District of Columbia Circuit. The Court of Appeals has denied Mylan's motion for a stay of the judgment pending the appeal.

For the 12 months ending August 31, 2012, Actos and its generic equivalents had total US sales of around $2.7 billion, according to IMS Health data quoted by Watson.